OneTrust

Associate Site Manager – Clinical Research Associate

OneTrust

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇨🇦 Canada

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Job Level

JuniorMid-Level

Tech Stack

Google Cloud Platform

About the role

  • You are the primary point of contact for the study site; liaison with study teams.
  • Your responsibilities include actively identifying and driving patient recruitment strategies at assigned sites.
  • You are responsible for monitoring the study/site according to GCP standards and J&J GCO SOPs, both on-site and with remote contacts.
  • You will provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
  • You will ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all study timelines.
  • You will work closely with the local study operations team to resolve protocol and site-specific issues.
  • You will use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (TMF) as required.

Requirements

  • Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred.
  • Minimum of 1 year experience in onsite and offsite (remote) monitoring ; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
  • Pharmaceutical industry clinical research trial experience preferred.
  • Analytical/risk-based monitoring experience is highly preferred.
  • Knowledge of several therapeutic areas is an asset (preferably including oncology).
  • In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • Ability to operate and use various systems and databases (e.g., CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting).
  • Fluent in English language.
Benefits
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial monitoringpatient recruitment strategiesanalytical monitoringrisk-based monitoringGood Clinical PracticeICH guidelinesregulatory compliancesite trainingbiological sciences knowledgetherapeutic area knowledge
Soft skills
communicationproblem-solvingcollaborationorganizational skillsattention to detailtime managementinterpersonal skillsadaptabilityleadershipinitiative
Certifications
Bachelor of ScienceRegistered Nurse (R.N.)